Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study

Study Purpose

This is a prospective, descriptive, observational research study designed to observe and
document the clinical practice by domain experts, and how the knowledge of new findings that
are published in the medical literature affect clinical decision making.
The study will evaluate risk factors and co-variants, including genetic variants that are
associated with disease progression such as pain, inflammation, organ dysfunction, disability
and quality of life.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

- Ability to read and write in English;
- Ability to provide informed consent
Control Subjects
• UPMC patients age 12 years without a chronic disorder.

Exclusion Criteria:

- Chronic infectious disease as the primary medical problem
- Less than 12 years of age
- Inability of the subject to understand the protocol
- Inability to the subject provide informed consent

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

The Genomic Resource to Enhance Available Therapies (GREAT1.0) Study is a research program
for personalized medicine. It is a highly annotated genetic and biosample resource for
multiple nested observational cohort studies. It is designed to begin to understand the
mechanisms underlying complex diseases using clinical information from the UPMC electronic
health record (EHR), from case-report forms, and from biological samples.
Aim 1. To test the hypothesis that point-of-care electronic health record (EHR)-based
phenotyping and clinical measures will be useful for classifying patient by disease risk,
subtype, activity, complications, quality of life or using statistical or systems approaches.
Aim 2. To test the hypothesis that common diseases can be subtyped using genotype data.
Aim 3. To test the hypothesis biological samples will provide additional functional and
mechanistic information about subject health, disease or state.
The study will be conducted using UPMC patients and population controls. Consent will allow
EHR and/or case report form data, plus biological samples to be given a unique code number
and transferred to researchers for analysis. Consent will also allow for a secure link to be
maintained allowing the research data or samples to be updated, and to contact the clinical
team and/or subject to provide them with additional information.

Arms & Interventions

Arms

: Case/Chronic complex disorders

Chronic complex disorders are composed of multiple population sub classifications - many of which have not been fully defined. Thus, all eligible patients should be included to maximize study power. Sufficient numbers of controls, those individuals in the general population, who may or may not have complex disorders are needed to match future comparison studies for a subset of questions, and so should also be included.

: Control

The number of controls that are anticipated for this study is less than patient numbers since they will not be needed for calculating the minor allele frequency of the majority of genetic polymorphism of interest in genetic association studies. This data is already available in public and research databases. Controls will be useful for evaluating case report form questions, providing assessment of the local genetic pool, and for possibly participating in future studies as provided by the consent.

Interventions

Other: - venipuncture

Research blood collection is also an option via venipuncture if the subject is not scheduled for clinical testing. This will also be limited to 21cc of blood, up to 4 time a year, and with the approval of the attending physician.

We may also contact subjects to request additional blood, saliva, cheek swab, hair, urine, or stool with their permission. This will be limited to no more than 4 teaspoons of blood and will happen no more than 4 times per year.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

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